Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

A053100 — Class IIa MDD by IME-DC GmbH…

MD Atlas
IME-DC GmbH International Medical Equipment - Diabetes Care

EUDAMED last updated this device on Dec 27, 2022

A053100

B-04260155930058

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: IME-DC GmbH International Medical Equipment - Diabetes Care
UDI-DI code: 04260155930058
Reference / catalog number: A053100

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: IME-DC GmbH International Medical Equipment - Diabetes Care
SRN: DE-MF-000010393
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 2, 2020	Still on market
Romania	Jan 31, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260155930058
Basic UDI-DI: B-04260155930058
Reference / catalog number: A053100
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 30G

EMDN nomenclature code(s)

V010402LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

E53010B-04260155930423On the market A063060B-04260155930126On the market A063080B-04260155930119On the market A063120B-04260155930140On the market A063040B-04260155930164On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.